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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TREVOUX - USS PARIETEX COMP 3D PY 37X28CM NO THRX1 PARIETEX COMPOSITE MESH

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TREVOUX - USS PARIETEX COMP 3D PY 37X28CM NO THRX1 PARIETEX COMPOSITE MESH Back to Search Results
Catalog Number PCO3728
Event Date 06/22/2009
Event Type  Injury  
Event Description

Procedure type: hernia. According to the reporter: as patient was coming out of anesthesia, the patient tore out the product from the suture half at the fascia side as well as 3cm. The surgeon removed the product and used a c-quin mesh.

 
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Brand NamePARIETEX COMP 3D PY 37X28CM NO THRX1
Type of DevicePARIETEX COMPOSITE MESH
Manufacturer (Section D)
TREVOUX - USS
116 avenue du formans
trevoux F-01 600
FRANCE F-01600
Manufacturer (Section G)
TREVOUX - USS
116 avenue du formans
trevoux F-01 6
FRANCE F-016
Manufacturer Contact
terry callahan
60 middletown ave.
north haven , CT 06473
2034926273
MDR Report Key1420303
Report Number9615742-2009-00074
Device Sequence Number1
Product CodeFTL
Report Source Manufacturer
Source Type User facility
Reporter Occupation Unknown
Type of Report Initial
Report Date 06/30/2009
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/22/2009
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberPCO3728
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Date Manufacturer Received06/30/2009
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? Yes
Type of Device Usage Unkown

Patient TREATMENT DATA
Date Received: 07/22/2009 Patient Sequence Number: 1
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